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Comparison of Vitamin B12 Supplementation to Selective Serotonin Reuptake Inhibitor (SSRI) Versus SSRI Antidepressant Treatment Alone

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Aga Khan University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00939718
First received: July 14, 2009
Last updated: May 28, 2010
Last verified: May 2010
History of Changes
  Purpose

While treating depression, significant numbers respond poorly to anti-depressants; one cause is vitamin B12 deficiency. The investigators are conducting an open label randomized controlled trial to investigate difference in response to SSRI monotherapy alone versus SSRI and intramuscular B12 replacement in people with low-normal B12 levels. 300 participants will be allocated to each arm of intervention at out patient clinics of the department of Psychiatry at Aga Khan University Hospital, Karachi Pakistan. Baseline and 3 month measurement of depression will be on Hamilton Rating Scale for Depression (Urdu version) and response rates compared.


Condition Intervention
Major Depressive Disorder
 Dietary Supplement: Vitamin B12

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Vitamin B12 Supplementation and SSRI to SSRI Monotherapy in Treating Depression With Low Normal B12: A Randomized Open Label trialComparison of Vitamin B12 Supplementation to SSRI Versus SSRI Antidepressant Treatment Alone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Decline in HAM-D score of 20% or more from baseline indicating improvement in Depression. [ Time Frame: 03 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 268
Study Start Date: April 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin B12 with antidepressants
Subjects in this arm will receive vitamin B12 supplement (injectable)along with their routine antidepressant treatment as prescribed by their primary physicians. subjects will be blind to their arm allocation and will receive injections in a concealed manner with injection vials covered with foil.
 Dietary Supplement: Vitamin B12
Vitamin B12 injections containing methylcobalamin 1000 mcg given once every six months along with the routine antidepressant treatment.
Other Name: Injection Bevidox intramuscular
Placebo Comparator: Placebo injections dextrose water
Subjects in this arm will receive placebo injections which will contain only dextrose water. They will also receive 6 injections on a weekly basis and the injection vials will be covered with foil to ensure masking.
 Dietary Supplement: Vitamin B12
Vitamin B12 injections containing methylcobalamin 1000 mcg given once every six months along with the routine antidepressant treatment.
Other Name: Injection Bevidox intramuscular

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  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults between ages 18 to 64 years who meet the criteria for a depressive episode as measured by a score of ≥ 16 on first 17 items of HAM-D (Urdu version.
  • Patients with low normal B12 levels in serum (>191 but < 300 pg/ml)
  • Those who will provide informed consent

Exclusion Criteria:

  • Patients with concurrent unstable medical illness
  • History of manic episodes or psychotic illness
  • Psychotic symptoms within depressive episode
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939718

Locations
Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Study Chair: Anwer Siddiqui, PhD Aga Khan University
  More Information

No publications provided

Responsible Party: Ehsan Ullah Syed ; Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT00939718     History of Changes
Other Study ID Numbers: 081011PSY
Study First Received: July 14, 2009
Last Updated: May 28, 2010
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
depression;vitamin B12;randomized control trial

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Serotonin Uptake Inhibitors
Psychotropic Drugs
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Hematologic Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on May 19, 2013